Study of Scaling and Root Planing With PerioWave Versus Scaling and Root Planing Alone in Chronic Periodontitis

Ondine Biomedical

Status and phase: Unknown; Phase 4

Conditions: Periodontitis

Treatments: Procedure: Scaling and Root Planing; Device: PerioWave

Study type: Interventional

Funder types: Industry

Identifiers

NCT00297531

ORL-0605-4

Details and patient eligibility

About

This study is to determine whether scaling and root planing (SRP) followed by photodynamic disinfection results in improved outcomes that persist over time in adults with chronic periodontitis when compared with subjects with SRP alone.

Full description

Extensive research has shown that lethal photosensitization with low levels of laser light is an effective method of killing numerous types of organisms. This therapy avoids the use of antibiotics along with their potential side effects. The initial application of this therapy to the oral cavity is particularly appropriate since the therapy can be applied topically either in a specific or general fashion, killing is immediate and resistance is unlikely as it is free radical-mediated. In addition, the disease states being treated (gingivitis & periodontitis) are highly prevalent and associated with significant morbidity. The equipment and costs of this therapy are simple, easily applied and relatively inexpensive compared with current therapies. Based on the scientific data to date this therapy has the potential of significantly improving the oral health of those affected.

This is a pivotal, prospective, randomized, examiner blinded, multicenter study to evaluate the effect of a single treatment of photodynamic disinfection in adults with chronic periodontal disease.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult male or female over the age of 18
2. Having been diagnosed with chronic periodontitis
3. >18 fully erupted teeth
4. Has had no periodontal instrumentation in the four months prior to initiation of study treatment
5. Subject has at least 4 sites with pocket depth of 6-9 mm in at least two quadrants of the mouth.
6. Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study
7. The subject is capable of giving informed consent
8. Subject is willing to sign a consent form

Exclusion criteria

1. Is pregnant or nursing or who plans to become pregnant in the next 4 months
2. Having significant liver disease by subject report
3. Having an active malignancy of any type by subject report
4. Having chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
5. Having any significant disease (either acute or chronic) or who is taking medication with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of PerioWave®
6. Having an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis
7. Treatment with antibiotics within the 1-month period prior to beginning the study or any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements, etc) by report of the subject
8. Known allergy to methylene blue
9. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
10. Currently uses anti-coagulant therapy at therapeutic doses
11. Currently uses photosensitizing medications
12. Participated in investigational treatment in the last 30 days or expectation for using a separate investigational treatment during the time of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind